U.S. patent application number 10/976395 was filed with the patent office on 2006-05-04 for system and method for catheter-based septal defect repair.
Invention is credited to Jeffrey W. Chambers.
Application Number | 20060095052 10/976395 |
Document ID | / |
Family ID | 36263050 |
Filed Date | 2006-05-04 |
United States Patent
Application |
20060095052 |
Kind Code |
A1 |
Chambers; Jeffrey W. |
May 4, 2006 |
System and method for catheter-based septal defect repair
Abstract
The contents include occlusion and/or repair of congenital heart
defects including methods, apparatuses, and systems utilizing
catheter delivery in order to repair congenital heart defects. In
particular, a method of repair includes suturing a septal tissue
proximate defect in order to repair the defect with a device
introduced through a bodily lumen of a patient. A repair device can
include an expansion assembly, a suture delivering portion, and a
suture receiving portion.
Inventors: |
Chambers; Jeffrey W.;
(Plymouth, MN) |
Correspondence
Address: |
DICKE, BILLIG & CZAJA, P.L.L.C.
FIFTH STREET TOWERS
100 SOUTH FIFTH STREET, SUITE 2250
MINNEAPOLIS
MN
55402
US
|
Family ID: |
36263050 |
Appl. No.: |
10/976395 |
Filed: |
October 29, 2004 |
Current U.S.
Class: |
606/139 |
Current CPC
Class: |
A61B 2017/00292
20130101; A61B 2017/047 20130101; A61B 17/0469 20130101; A61B
17/0057 20130101; A61B 2017/00243 20130101; A61B 2017/00575
20130101 |
Class at
Publication: |
606/139 |
International
Class: |
A61B 17/10 20060101
A61B017/10 |
Claims
1. A method of repairing a septal defect in a septum defined by
septal tissue, the method comprising: introducing a guiding
catheter into a bodily lumen of a patient; delivering a repair
device proximate the septal defect via the guiding catheter,
wherein the repair device includes, a suture delivering portion
maintaining a suture, and a suture receiving portion; positioning
the suture at a first location proximate the septal defect with the
repair device; positioning the suture at a second location
proximate the septal defect with the repair device; pressing
opposing sides of the septum together with the repair device;
driving the suture through the septal tissue at the first location
with the repair device; driving the suture through the septal
tissue at the second location with the repair device; capturing the
suture with the repair device; and tying the suture.
2. The method of claim 1, wherein the suture is captured with the
suture receiving portion after the suture has been driven through
the septal tissue.
3. The method of claim 1, further comprising: positioning a second
suture at a third location proximate the septal defect with the
repair device, wherein the second suture is maintained by the
suture delivering portion; driving the second suture through the
septal tissue at the third location with the repair device;
positioning the second suture at a fourth location proximate the
septal defect with the repair device; driving the second suture
through the septal tissue at the fourth location with the repair
device; capturing the second suture with the repair device; and
tying the second suture.
4. The method of claim 1, wherein capturing the suture with the
repair device includes, capturing the suture within a mesh material
of the suture receiving portion.
5. The method of claim 1, wherein capturing the suture with the
repair device includes, capturing the suture within a porous
material of the suture receiving portion.
6. The method of claim 1, wherein capturing the suture with the
repair device includes, capturing the suture by magnetic attraction
with the suture receiving portion.
7. The method of claim 1, wherein capturing the suture with the
repair device includes, capturing the suture by frictional
engagement with the suture receiving portion.
8. The method of claim 1, wherein the septum is the atrial septum
and the septal defect is a defect in the atrial septum.
9. The method of claim 1, wherein the septal defect is a patent
foramen ovale.
10. The method of claim 1, wherein the septum is the ventricular
septum and the septal defect is a defect in the ventricular
septum.
11. The method of claim 1, wherein positioning the suture at the
first location with the repair device includes: positioning a first
end of the suture at the first location proximate the septal
defect; wherein driving the suture through the tissue at the first
location with the repair device includes: driving the first end of
the suture from a first side of the septum to a second side of the
septum with the suture delivering portion; wherein positioning the
suture at the second location with the repair device includes:
positioning a second end of the suture at the second location
proximate the septal defect; wherein driving the suture through the
tissue at the second location with the repair device includes:
driving the second end of the suture from the first side of the
septum to the second side of the septum with the suture delivering
portion; and wherein capturing the suture with the repair device
includes: capturing the first end and the second end of the suture
with the suture receiving portion at the second side of the
septum.
12. The method of claim 11, wherein the repair device further
includes: a first unit defining the suture delivering portion; and
a second unit defining the suture receiving portion; wherein the
first unit and the second unit are coaxially received together and
both the first unit and the second unit are coaxially received
within the guide catheter; and further wherein repairing a septal
defect in a septum defined by septal tissue further comprises,
delivering the first unit to the first side of the septum;
delivering the second unit to the second side of the septum;
positioning the suture receiving portion and suture delivering
portion relative to one another such that the suture receiving
portion is aligned to capture the suture as delivered by the suture
delivering portion; and pressing the septal tissue between the
first unit and the second unit.
13. The method of claim 12, further comprising: delivering a
transseptal needle proximate the septal defect via the repair unit;
puncturing the septum with a transseptal needle such that the
needle extends between the first side of the septum and a second
side of the septum; and guiding the second unit over the
transseptal needle and through the septal tissue from the first
side of the septum to the second side of the septum.
14. The method of claim 12, further comprising: guiding the second
unit through the septal defect from the first side of the septum to
the second side of the septum.
15. The method of claim 12, wherein the first end of the suture is
affixed to a first suture needle and the second end of the suture
is affixed to a second suture needle, and further wherein capturing
the first and second ends of the suture with the suture receiving
portion includes driving the first and second needles into the
suture receiving portion.
16. The method of claim 1, wherein positioning the suture at the
first location with the repair device includes: positioning a first
end of the suture at the first location proximate the septal
defect; wherein driving the suture through the tissue at the first
location with the repair device includes: driving the first end of
the suture from a first side of the septum to a second side of the
septum with the suture delivering portion; wherein positioning the
suture at a second location with the repair device includes:
positioning the first end of the suture at the second location
proximate the septal defect; wherein driving the suture through the
tissue at the second location with the repair device includes:
driving the first end of the suture from the second side of the
septum to the first side of the septum with the suture delivering
portion; and wherein capturing the suture with the repair device
includes: capturing the first end of the suture with the suture
receiving portion at the first side of the septum.
17. The method of claim 16, wherein the suture delivering portion
includes a first end of the suture affixed to a needle configured
to take a curvilinear shape, and further wherein driving the first
end of the suture through the tissue at the first and second
locations with the suture delivering portion includes driving the
needle through the tissue at the first and second locations.
18. The method of claim 16, wherein the suture delivering portion
includes a first end of the suture affixed to a needle, the needle
removably connected to a push member configured to take a
curvilinear shape, and further wherein driving the first end of the
suture through the tissue at the first and second locations with
the suture delivering portion includes driving the needle through
the tissue at the first and second locations with the push
member.
19. The method of claim 1, further comprising: securing a patch
across the septal defect at one side of the septum.
20. A septal defect repair system for repairing a septal defect in
a septum defined by septal tissue, the system comprising: a guide
catheter disposed within a bodily lumen of a patient; and a repair
device disposed within the guide catheter, the repair device
including: an expansion assembly configured to press opposing sides
of the septum together, a suture delivering portion maintaining a
suture and configured to drive an end of the suture through the
septal tissue proximate the septal defect, a suture receiving
portion configured to capture the end of the suture from the suture
delivering portion.
21. The system of claim 20, wherein the suture receiving portion is
defined by a plurality of radially extending petals.
22. The system of claim 20, wherein the suture receiving portion
includes a wire mesh material.
23. The system of claim 20, wherein the suture receiving portion
includes a plurality of conical receptacles, each receptacle
including a porous material at the base of the receptacle.
24. The system of claim 20, wherein the suture delivery portion
includes at least one needle configured to take a curvilinear
shape, the needle maintaining the end of the suture.
25. The system of claim 20, wherein the suture delivery portion
includes a plurality of push wire assemblies, each one of the
plurality of push wire assemblies including: a needle catheter; a
push member slidably disposed within the needle catheter; and a
suture needle removably affixed to an end of the push wire; wherein
the end of the suture is affixed to the suture needle and the
suture receiving portion is configured to capture the end of the
suture from the suture delivering portion by capturing the suture
needle.
26. The system of claim 25, wherein the push member is configured
to take a curvilinear shape upon extension from the needle
catheter.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to occlusion and/or
repair of defects of the heart. More specifically, the present
invention relates to methods, apparatuses and systems utilizing
catheter delivery through a bodily lumen of a patient in order to
repair congenital heart defects.
BACKGROUND
[0002] Congenital heart disease occurs in approximately six to ten
children born out of one thousand. In general terms, congenital
heart defects are abnormalities in heart structure formation
arising during fetal development. While symptoms of such defects
may become apparent following childbirth or early childhood, the
presence of such defects, and symptoms arising therefrom, may not
be recognized until well later into adulthood.
[0003] Congenital heart defects include, for example, Atrial Septal
Defects (ASDs), Ventricular Septal Defects (VSDs), and Patent
Ductus Arteriosis (PDA). Generally speaking, defects in the septum
such as ASDs and VSDs are some of the most commonly occurring
congenital heart defects. For reference, the septum is composed of
muscular tissue and acts to divide the heart into left and right
sides. More specifically, the septum includes an atrial septum and
a ventricular septum. As the name indicates, ASDs include improper
formation of the atrial septum, the wall separating the right
atrium and the left atrium. VSDs are generally a hole or other
defect in the ventricular septum, the wall separating the right
ventricle and the left ventricle. The presence of such congenital
heart defects can result in relatively mild symptoms such as
decreased energy, shortness of breath, or increased rate of
fatigue. However, congenital heart defects can also lead to more
serious problems including heart failure, irreversible pulmonary
vascular disease, or paradoxic embolization.
[0004] One type of ASD is a Patent Foramen Ovale ("PFO"). During
fetal development a passageway for blood exists between a septum
primum and a septum secundum, which later combine to form the
atrial septum. This passage, or opening, is used during fetal
development to facilitate blood flow between the two atria in a
growing fetus. In non-defective hearts, the opening closes
following childbirth due to increased pressure on the left side of
the heart. However, in instances where the atrial septum is
defective, the passageway remains active after childbirth. This
residual opening is a Patent Foramen Ovale. PFOs can be said to act
like selective valves in many cases. In operation, the "valve"
might only open under certain pressure conditions. For instance,
pressure exerted on the heart when a person is sneezing or
otherwise straining himself or herself can cause reverse blood flow
through a PFO.
[0005] In the past, congenital heart defects have largely been
treated through open-chest surgery or other invasive procedures
requiring access through the chest or torso. Closure, or
alternatively occlusion, of some congenital defects has also been
accomplished utilizing percutaneous techniques. In particular, a
transcatheter approach has been utilized to deliver occlusion
devices for ASDs, PDAs, PFOs, and VSDs, for example. Generally,
these occlusion devices are delivered to a septal defect and then
expanded within the defect in order to both occlude the defect, and
anchor the occlusion device in a desired position.
[0006] However, the occlusion device technologies mentioned above
are potentially hampered by inherent shortcomings. For example,
occlusion devices are often limited to use with centrally located
defects having both well-defined margins and limited sizes.
Furthermore, implantation failures including device migration,
embolization, and residual shunts occur at undesirable levels.
Indeed, repair of such failures can require emergency open chest
surgery. Additionally, holes at the bottom of the atrial septum and
large holes in the middle of the atrial septum can be problematic
to occlusion device use, and may still require open chest surgery
in order to either suture a defect closed, or suture a patch to the
defect.
[0007] While catheter-based methods can include the shortcomings
mentioned above, open chest surgery is still less desirable than
less invasive catheter-based methods. In particular, during open
chest surgery the heart is normally put under cardioplegic arrest
with circulation maintained by cardiopulmonary bypass. The
invasiveness of such procedures, as well as stoppage of the heart,
drastically increases the risks of death and prolonged recovery. As
such, a need exists for methods and associated devices capable of
repairing congenital defects via less invasive means, including
repairing those defects not amenable to the use of occlusion
devices. More specifically, a need exists for a method and
apparatus capable of allowing a surgeon to suture a septal defect,
or suture a patch to a septal defect, utilizing a catheter delivery
method.
SUMMARY
[0008] One aspect of the present invention relates to a method of
repairing a septal defect in a septum defined by septal tissue. In
particular the method includes introducing a guiding catheter into
a bodily lumen of a patient and delivering a repair device
proximate the septal defect via the guiding catheter. The repair
device can include a suture delivering portion maintaining a suture
and a suture receiving portion. Opposing sides of the septum are
pressed together with the repair device. Further, the suture is
positioned at a first location proximate the septal defect with the
repair device and driven through the tissue at the first location
with the repair device. The suture is positioned at a second
location proximate the septal defect and driven through the tissue
at the second location with the repair device. Additionally, the
suture is captured with the repair device and tied to repair the
defect.
[0009] Another aspect of the present invention includes positioning
a first end of the suture at the first location proximate the
septal defect and driving the first end of the suture from a first
side of the septum to a second side of the septum with the suture
delivering portion of the repair device. The suture is positioned
at the second location proximate the septal defect by positioning a
second end of the suture at the second location proximate the
septal defect. The second end of the suture is driven from the
first side of the septum to the second side of the septum with the
suture delivering portion. The first and second ends of the suture
are captured with the suture receiving portion at the second side
of the septum.
[0010] Yet another aspect of the present invention includes
positioning the suture at the first location with the repair device
by positioning a first end of the suture at the first location
proximate the septal defect. The suture is driven through the
tissue at the first location by driving the first end of the suture
from a first side of the septum to a second side of the septum with
the suture delivering portion. The first end of the suture is
positioned at the second location proximate the septal defect and
driven from the second side of the septum to the first side of the
septum with the suture delivering portion. The first end of the
suture is captured with the suture receiving portion at the first
side of the septum and the suture is tied.
[0011] Another aspect of the present invention relates to a septal
defect repair system for repairing a septal defect in a septum
defined by septal tissue. In particular, the system comprises a
guide catheter disposed within a bodily lumen of a patient and a
repair device disposed within the guide catheter. The repair device
includes an expansion assembly configured to press opposing sides
of the septum together and a suture delivering portion maintaining
a suture and configured to drive an end of the suture through the
septal tissue proximate the septal defect. The repair device also
includes a suture receiving portion configured to capture the end
of the suture from the suture delivering portion.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] The accompanying drawings are included to provide further
understanding of the present invention and are incorporated in and
constitute a part of this Specification. The drawings illustrate
some of the embodiments of the present invention and, together with
the description, help explain the principles of the invention.
Other embodiments of the present invention and many of the intended
advantages of the present invention will be readily appreciated
with reference to the Detailed Description when considered in
connection with the accompanying drawings.
[0013] In the drawings, like reference numerals designate like
parts throughout the figures, wherein:
[0014] FIG. 1A shows a plan view of an embodiment repair device in
accordance with the present invention.
[0015] FIG. 1B shows a cross-sectional view along line 1B-1B of
FIG. 1A.
[0016] FIG. 1C illustrates an enlarged view of the area designated
1C in FIG. 1B.
[0017] FIG. 2A is a cross-sectional view of the repair device of
FIG. 1A similar to that of FIG. 1B, with first and second units in
an expanded state.
[0018] FIG. 2B illustrates an end view of the repair device of FIG.
1A, with the first and second units in an expanded state.
[0019] FIGS. 3 to 12B illustrate a method of repairing a septal
defect in accordance with the present invention.
[0020] FIG. 13A is a cross-sectional view along a central axis Y of
another embodiment first unit of a repair device in accordance with
the present invention.
[0021] FIG. 13B is an end view of the alternative embodiment of
FIG. 13A.
[0022] FIG. 14 is a cross-sectional view along a central axis Y of
yet another embodiment repair device in accordance with the present
invention.
DETAILED DESCRIPTION
[0023] In the following Detailed Description, reference is made to
the accompanying drawings, which form a part hereof, and in which
is shown by way of illustration specific embodiments in which the
invention may be practiced. In this regard, directional
terminology, such as "top," "bottom," "front," "back," "leading,"
"trailing," etc., is used with reference to the orientation of the
figure(s) being described. Because components of embodiments of the
present invention can be positioned in a number of different
orientations, the directional terminology is used for purposes of
illustration and is in no way limiting. It is to be understood that
other embodiments may be utilized and structural or logical changes
may be made without departing from the scope of the present
invention. The following detailed description, therefore, is not to
be taken in a limiting sense, and the scope of the present
invention is defined by the appended claims.
[0024] One embodiment of a catheter delivered septal defect repair
device 20 in accordance with the present invention is provided in
FIGS. 1A and 1B. The repair device 20 is configured for delivery
into a body of a patient (not shown) via a catheter introduced into
a bodily lumen of the patient, such bodily lumen including veins
and/or arteries of the patient (not shown). The repair device 20
defines a central axis X and comprises a first unit 22. The first
unit 22 includes a body 24 defining an inner lumen 26 and an
expansion assembly 28 defining a suture receiving portion 29 of the
repair device 20. In one embodiment, the repair device 20 further
comprises a second unit 30. The second unit 30 includes a body 32
defining an inner lumen 34, an expansion assembly 35, and a suture
delivering portion 36. In general terms, the repair device 20 can
be configured to incorporate a "nested" design in order to
facilitate its introduction into a body of a patient (not shown)
via catheter insertion. As such, in one embodiment, the first unit
22 is configured for insertion into a catheter and to also accept
at least a portion of the second unit 30 within the inner lumen 26
of the first unit 22. With this configuration, for example, both
the first unit 22 and the second unit 30 can be concurrently
inserted into the body of the patient via subcutaneous methods.
However, the operative efficacy of the repair device 20 will be
made clearer with reference to the text that follows.
[0025] In one embodiment, the first unit body 24 is tubular
defining an outer transverse perimeter. They body 24 can be formed
of a metallic materials, such as Nitinol.RTM., plastics, or
materials similar to those known for use in constructing catheters.
The body 24 preferably defines a generally rectangular outer
transverse perimeter in cross-section. As such, the body 24
preferably defines four faces 37 (FIG. 2B). However, the body 24
can also define an outer transverse perimeter having other
cross-sectional shapes. In one embodiment, the body 24 defines a
maximum transverse diameter compatible with insertion into a
catheter (not shown). The body 24 also defines a generally
rectangular transverse perimeter of the inner lumen 26.
[0026] The first unit body 24 extends from a proximal end 40
through a length to a distal end 38. The inner lumen 26 also
extends from the proximal end 40 to the distal end 38. Furthermore,
and as will be described in greater detail below, the first unit 22
is configured such that the first unit 22 can be manipulated from
outside the body of the patient (not shown) to repair a septal
defect (not shown). As such, in one embodiment, the body 26 defines
a length such that the proximal end 40 can be manipulated from
outside the body of the patient while the distal end 38 is located
proximate the septal defect. However, it should be understood that
the first unit 22 can alternatively incorporate wires or other
fixtures extending from the proximal end 40 to allow external
maneuvering of the first unit 22 while the distal end 38 of the
first unit body 26 is located inside the patient.
[0027] In one embodiment, the first unit 22 includes the expansion
assembly 28 such that the first unit 22 is capable of being
transitioned between an expanded state and a collapsed state. In
one embodiment, the expansion assembly 28 includes a plurality of
nests 42 formed in the body 24 and a plurality of projections 44,
each of the plurality of projections 44 maintained by a
corresponding one of the plurality of nests 42. As will be
described below, each of the plurality of projections 44 is
maintained within a respective one of the plurality of nests 42
with a pin 45 and an actuation wire 67. Although the expansion
assembly 28 includes the above-described features, it should be
understood that the expansion assembly 28 can also include,
springs, balloons, or other expandable structures without departing
from the scope of the present invention.
[0028] In one embodiment, each one of the plurality of nests 42 is
generally rectangular in shape and is formed lengthwise in the body
24. A first one of the plurality of nests 42 defines a proximal end
46, a lengthwise midpoint 48, and a distal end 50. While the first
one of the plurality of nests 42 is described in greater detail
herein, it is to be understood that a remainder of the plurality of
nests 42 can incorporate similar features to those described in
association with the first one of the plurality of nests 42. In one
embodiment, each one of the plurality of nests 42 is preferably
disposed radially about the body 24. As such, one embodiment
includes four nests 42, each of the four nests 42 formed in a
respective one of the faces 37 of the body 24. As shown, each one
of the plurality of nests 42 is formed through a thickness of the
body 24. However, it is to be understood that in other embodiments,
each one of the plurality of nests 42 can be formed partially
through the thickness of the body 24.
[0029] Each of the plurality of nests 42 includes a first pin track
52 (shown with dotted lines in FIG. 1A and shown partially covered
in FIG. 1B) formed in the thickness of the body 24 and extending
along a nest first side 54 from the lengthwise midpoint 48 to the
distal end 50. A corresponding second pin track 56 (shown with
dotted lines in FIG. 1A) is also formed in the thickness of the
body 24, extending along an opposing nest second side 58 from the
lengthwise midpoint 48 to the distal end 50. In other words, in one
embodiment, each of the plurality of nests 42 includes an opposing
pair of pin tracks 52,56 extending along opposing nest sides 54,58.
As will be described in greater detail below, the two pin tracks
52,56 are configured to slidably maintain the pin 45. The two pin
tracks 52,56 can also be configured to rotatably maintain the pin
45.
[0030] In one embodiment, each of the plurality of projections 44
defines a proximal end 62, a lengthwise midpoint 64, and a distal
end 66. In one embodiment, each of the plurality of projections 44
is configured such that an actuation wire 67 can be affixed to the
proximal end 62.
[0031] The plurality of projections 44 can be generally similar in
size to the corresponding nests 42. As such, in one embodiment,
each of the plurality of projections 44 is a generally rectangular
and flat petal. However, each of the plurality of projections 44 is
not as wide or as long as the nest 42 in which it is maintained. In
this manner, the plurality of projections 44 can be maintained in
the corresponding one of the nests 42 without interfering with
either of the opposing sides 54,58 or proximal and distal ends
46,50. Furthermore, each of the plurality of projections 44 is
configured to be maintained within the corresponding nest 42
without protruding from the outer transverse perimeter of the body
24 when the first unit 22 is in the collapsed state.
[0032] As shown in FIGS. 1A and 1B, each of the plurality of
projections 44 forms a pin slot 68 configured to accept the pin 45.
In one embodiment, the pin slot 68 originates at a proximal end 69
proximate the proximal end 62 of the projection 44 and extends
proximate to the lengthwise midpoint 64. As shown by the dotted
lines in FIG. 1B, the pin slot 68 extends widthwise entirely from a
first side 70 to an opposing second side 72 through a thickness of
the projection 44. In this manner, the pin 45 can be slidably
retained within the pin slot 62 while remaining partially exposed
from the opposing sides 70,72 of the projection 44.
[0033] In one embodiment, the first unit 22 defines, or includes,
the suture receiving portion 29 of the repair device 20. The suture
receiving portion 29 can be generally described as a suture needle
retaining structure. As shown in FIGS. 1A and 1B, each of the
plurality of projections 44 can define at least part of the suture
receiving portion 29. In one embodiment, the suture receiving
portion 29 includes a conical receptacle that is generally
complementary in shape to a suture needle with a porous material at
a base of the conical receptacle (not shown). Additionally, it
should be understood that other materials that can promote
frictional engagement of a suture and/or suture material (not
shown) could also be employed. In another embodiment, and as shown
in FIGS. 1A and 1B, the suture receiving portion 29 is defined by
at least a portion of the plurality of projections 44 being formed
of a mesh material suitable for capturing a suture. In an exemplary
embodiment, the plurality of projections 44 are formed of
Nitinol.RTM. wire-mesh material. However, alternative suture
receiving portions 29 can be incorporated by the first unit 22 and
defined by the plurality of projections 44. For example, the suture
receiving portion 29 can include forming at least a portion of the
plurality of projections 44 of a relatively soft material. In other
embodiments, the suture receiving portion 29 can also include
detents, magnets, adhesives, locking mechanisms or other features
suited to suture needle capture. It will be understood with
reference to the text that follows that the second unit 30 can also
define, or include, a suture receiving portion of the repair device
20.
[0034] In one embodiment, the pin 45 defines a pin central portion
70, a pin first end 72, and an opposing pin second end 74. The pin
45 can be a solid rod formed of a material such as Nitinol.RTM.. As
shown in FIG. 1B, the pin 45 defines a generally circular
transverse cross-section. In alternative embodiments, the pin 45
can also define a cam shape in transverse cross-section.
[0035] In one embodiment, the actuation wire 67 is adapted to be
affixed to the proximal end 46 of the corresponding projection 44.
Furthermore, the actuation wire 67 preferably defines a length such
that a proximal end 76 of the actuation wire 67 can be manipulated
from a point outside of the body of the patient (not shown) while a
distal end 78 of the actuation wire 67 is affixed to the
corresponding projection 44. The actuation wire 67 can be formed of
a variety of materials, but in one embodiment is formed of
Nitinol.RTM. wire. As will become more evident below, the actuation
wire 67 is configured such that an operator (not shown)
manipulating the proximal end 76 of the actuation wire 67 can push
and/or pull the wire in order to transition the first unit 22
between the expanded and the collapsed states.
[0036] The repair device 20 is shown in FIGS. 1A and 1B with the
first unit 22 in a collapsed state. The plurality of projections 44
and the plurality of nests 42 are preferably assembled together to
define the collapsed state shown in FIGS. 1A and 1B as follows. The
plurality of projections 44 are maintained within corresponding
ones of the plurality of nests 42 such that the plurality of
projections 44 do not protrude, or extend outwardly from, the
corresponding nest 42. In other words, the plurality of projections
44 generally lie "in plane" with the corresponding nests 42 and a
surrounding portion of the body 24.
[0037] As alluded to above, the pin 45 acts to help maintain the
projection 44 in the corresponding nest 42, as the central portion
70 of the pin 45 is slidably maintained in the pin slot 68.
Further, the pin first end 72 is slidably maintained in the first
pin track 52 and the pin second end 74 is slidably maintained in
the second pin track 56. With this arrangement, the pin 45 can be
slid within both the pin slot 68 and the opposing pin tracks 52,56.
Further, the pin slot 68, the opposing pin tracks 52,56, or both,
can be configured to allow the pin 45 to rotate. As will be
described below, such a configuration allows the projection 44 to
be moved distally within the corresponding nest 42 in which it
resides, while also allowing the distal end 66 of the projection 44
to rotate outward away from the body 24 to the position shown in
FIGS. 2A and 2B.
[0038] Additionally, it is to be understood that tension on the
actuation wire 67 aids in maintaining the corresponding projection
44 "in plane" as shown. In one embodiment, the actuation wire 67
extends through a channel 80 formed through the thickness of the
body 24. In particular, the actuation wire 67 extends proximally
beyond the body proximal end 40. However, the actuation wire 67 can
alternatively take an external path to the body 36 to extend beyond
the body proximal end 40. Further, the actuation wire 67 can also
extend over an internal path, e.g., within the inner lumen 26, to
extend beyond the body proximal end 40. In one embodiment, the
actuation wire 67 extends a sufficient length such that an operator
(not shown) is capable of manipulating the actuation wire proximal
end 76 from outside the body of the patient (not shown).
[0039] With reference from FIGS. 1A and 1B to FIGS. 2A and 2B, a
manner of transitioning the first unit 22 from the collapsed state
(FIGS. 1A and 1B) to the expanded state (FIGS. 2A and 2B) follows.
In particular, the actuation wire 67 is moved forward, or distally,
resulting in the corresponding projection 44 sliding distally over
the pin 45 associated therewith. In one embodiment, the distal end
66 of the projection 44 is configured such that it is guided by a
distal end 50 of the corresponding nest 42 outward from the central
longitudinal axis X. In this manner, the projection 44 will also
rotate about the pin 45. In one embodiment, the actuation wire 67
is affixed to the proximal end 62 of the corresponding projection
44. As shown in FIG. 1B, the actuation wire 67 can be affixed to
the proximal end 62 at an offset in order to facilitate the outward
extension, or deflection of the projection distal end 66. In other
words, distal movement of the actuation wire 67 can be partially
directed toward the central longitudinal axis X by the offset in
order to push the proximal end 62 of the corresponding projection
44 inward towards the central longitudinal axis X. As shown, the
distal end 66 of the projection 44 then deflects, or projects,
outward from a central longitudinal axis X of the first unit body
24.
[0040] As the projection 44 slides distally and rotates outwardly,
the pin 45 eventually reaches the proximal end 69 of the pin slot
68. In one embodiment, the projection 44 extends at a perpendicular
angle to the central longitudinal axis X when the pin 45 has
reached the pin slot proximal end 69. The continued distal
actuation, or pushing, of the actuation wire 67 can then result in
further distal movement of the projection 44. In particular, the
pin 45 will slide distally within the two opposing pin tracks
52,54. Additionally, in one embodiment, the pin 45 will slide in
this manner after the projection 44 has been extended
perpendicularly to the central longitudinal axis X.
[0041] Additional means of accomplishing this perpendicularly
extended and distal actuation will be recognized by those of
ordinary skill in the art. For example, in one embodiment, this
type of actuation is partially accomplished by the pin 45 defining
a cam capable of interacting with the pin tracks 52,54, or
alternatively the pin slot 68. However, cam structures are simply
one means of causing the plurality of projections 44 to arrest
rotation at a perpendicular position relative to the central
longitudinal axis X. For example, those having ordinary skill in
the art will recognize that stops, additional linkages, or other
features can also be implemented to accomplish such movement.
[0042] The plurality of projections 44 will preferably take the
position shown in FIGS. 2A and 2B once the corresponding pins 45,
and consequently, the plurality of projections 44, have been slid
to the distal end 50 of the corresponding nests 42. In this
position, a proximal portion of the plurality of projections 44
will preferably abut against a portion of the first unit body 24
defining the nest distal end 50. Distal actuation, or pushing, of
the corresponding actuation wires 67 will preferably act to support
the projections 44 in this perpendicularly extended position, while
also maintaining the projections 44 at the distal end 50 of the
respective nests 42.
[0043] It should also be recognized that the first unit 22 can be
collapsed, or transitioned from the expanded to the collapsed state
shown in FIGS. 1A and 1B. In particular, transitioning the first
unit 22 from the expanded state to the collapsed state includes
proximal actuation, or pulling, of the actuation wires 67 to
effectuate a reverse series of events to those described in
association with expansion of the first unit 22. In other words,
expanding the first unit 22 includes pushing on the actuation wires
67, while collapsing the first unit 22 includes pulling on the
actuation wires 67. However, those of ordinary skill in the art
will recognize that alternative means of either expanding, or
collapsing the first unit 22, and in particular, actuation of the
plurality of projections 44, can be employed. For instance, in
alternative embodiments, spring mechanisms can be included in the
first unit 22 in order to facilitate expanding or collapsing the
first unit 22.
[0044] Returning to FIGS. 1A and 1B, and turning now to the second
unit 30, the second unit body 32 is tubular defining an outer
transverse perimeter in one embodiment. Generally, the second unit
body 32 can be formed with similar materials to those forming the
first unit body 24. In one embodiment, the second unit body 32
defines a generally rectangular outer transverse perimeter in
cross-section having a shape factor similar to that of the outer
transverse perimeter of the first unit body 24. Additionally, the
second unit body 32 defines a maximum outer transverse diameter
such that the second unit body 32 can be disposed within the inner
lumen 26 defined by the first unit body 24. With the embodiment
having a rectangular cross-section, the second unit body 32 defines
four faces 82 corresponding to the rectangular outer transverse
perimeter. However, the body 32 can define other cross-sectional
shapes with the outer transverse perimeter. In one embodiment, the
body 32 also defines a generally rectangular transverse perimeter
of the inner lumen 34. The second unit body 32 extends from a
proximal end 84 through a length to a distal end 86. Further, the
inner lumen 34 extends from the proximal end 84 to the distal end
86.
[0045] As will be described in greater detail below, the second
unit 30 is also configured to be manipulated from outside the body
of the patient to repair the septal defect in the body of the
patient (not shown). As such, in one embodiment, the body 32
defines a length such that the proximal end 84 can be manipulated
from outside the patient while the distal end 86 is located
proximate the septal defect. However, as with the first unit 22, it
should be noted that the second unit 30 could alternatively
incorporate additional wires or other fixtures extending from the
body 32 which allow external maneuvering of the second unit 30
while the distal end 86 of the second unit body 32 is located
inside the patient.
[0046] In one embodiment, the second unit 30 includes the expansion
assembly 35 such that the second unit 30 is also capable of
transitioning between an expanded state and a collapsed state. In
one embodiment, the expansion assembly 35 includes a plurality of
pockets 88 formed in the second unit body 32 and a plurality of
guide bodies 90, each one of the plurality of guide bodies 90
maintained by a corresponding one of the plurality of pockets 88.
In one embodiment, each of the plurality of guide bodies 90 is
maintained in a corresponding pocket 88 with a pin 92 and actuated
with an actuation wire 94. Although embodiment expansion assemblies
have been described as including the structures mentioned above, it
should be understood that the expansion assembly 28 could include
alternative structures such as balloons, springs, or other
expandable structures without departing from the scope of the
present invention.
[0047] While one of the plurality of pockets 88 is described below
in greater detail, it is to be understood that all of the pockets
88 can incorporate similar features. As shown in FIG. 1A, the
pocket 88 is generally rectangular in shape and is formed
lengthwise in the second unit body 32. The pocket 88 defines a
proximal end 96, a lengthwise midpoint 98, and a distal end 100.
Similarly to the first unit 22, the plurality of pockets 88 are
disposed radially about the second unit body 32. In particular, one
embodiment includes four pockets 88, each formed in a respective
one of the faces 82 of the body 32. As shown, each of the pockets
88 is formed through a thickness of the body 32. However, as with
the first unit 22, it is to be understood that in alternative
embodiments, the pockets 88 can be formed partially through the
thickness of the body 32.
[0048] As shown in dotted lines in FIG. 1A, the pocket 88 includes
a first female pin mount 102 formed in the thickness of the body
32. In particular, the first female pin mount 102 is formed at the
lengthwise midpoint 98 in a first side 104 of the pocket 88. A
corresponding second female pin mount 106 is formed in an opposing
second side 108. In particular, the second female pin mount 106 is
formed in the thickness of the body 32 at the lengthwise midpoint
98 of the pocket 88. As will be described in greater detail below,
the pin 92 is rotatably maintained within the two female pin mounts
102,106. In another embodiment, the pockets 88 can incorporate
structures similar to those described in association with the first
unit 22, including opposing pin tracks for maintaining the pin
92.
[0049] While one of the plurality of guide bodies 90 is described
in greater detail below, it is to be understood that each of the
plurality of guide bodies 90 can incorporate similar features. With
that in mind, the guide body 90 defines a proximal end 110, a
lengthwise midpoint 112, and a distal end 114. Additionally, guide
body 90 can define a similar shape factor to the corresponding
pocket 88. However, it is to be understood that the guide body 90
can include tapers or rounds, such as the taper toward the distal
end 114 as shown in FIG. 1A. In one embodiment, the guide body 90
is a generally rectangular and flat petal. In one embodiment, the
guide body 90 is not as wide or as long as the corresponding pocket
88. In particular, the guide body 90 is configured for reception
within the corresponding pocket 88 without interfering with either
of the opposing sides 104,108 or the proximal and distal ends
96,100 of the pocket 88.
[0050] In one embodiment, the guide bodies 90 are configured to be
maintained "in plane" within the respective pocket 88, without
protruding from the outer transverse perimeter of the body 32 when
the second unit 30 is in the collapsed state. Furthermore, when
expanded, the guide bodies 90 are configured to extend from the
central axis X less than the plurality of projections 44 of the
first unit 22 in the expanded state. As will be understood with
reference to the description below, this relative sizing can
facilitate suture needle capture in the suture receiving portion 29
of the first unit 22. Along these lines, in one embodiment, the
guide bodies 90 are formed of a solid material that can be
resistant to suture needle penetration. In another embodiment, at
least a portion of the guide bodies 90 defines the suture receiving
portion 29 of the repair device 20.
[0051] As shown in FIGS. 1A and 1B, the guide body 90 forms a pin
slot 116 configured to accept the pin 92. In one embodiment, the
pin slot 116 originates at a proximal end 118 proximate the
proximal end 110 of the guide body 90 and extends within a
thickness of the guide body 90 to a slot distal end 120 proximate
the lengthwise midpoint 112. As shown in FIG. 1B, the pin slot
proximal end 118 begins distal to the proximal end 114 such that
the pin 92 can be maintained within the thickness of the pin slot
116 as it slides between the proximal and distal ends 118,120 of
the pin slot 116.
[0052] In one embodiment, the pin 92 is a solid rod formed of a
material such as Nitinol.RTM.. In a related embodiment, the pin 92
defines a generally circular cross-section and defines a pin
central portion 122, a pin first end 124, and a pin second end 126.
In alternative embodiments, the pin 92 defines a cam shape in
transverse cross-section.
[0053] In one embodiment, the actuation wire 94 is configured for
fixation to the proximal end 110 of the corresponding guide body
90. The actuation wire 94 defines a length such that an actuation
wire proximal end 128 can be manipulated from a point outside of
the body of the patient (not shown) while an actuation wire distal
end 130 is affixed to the corresponding guide body 90. The
actuation wire 94 can be formed of a variety of materials, but in
one embodiment, is formed of Nitinol.RTM. wire.
[0054] The suture delivering portion 36 can be described in greater
detail with reference to FIGS. 1A, 1B, and 1C. In one embodiment,
the suture delivering portion 36 includes a plurality of push
member assemblies 132. In an exemplary embodiment, the number of
push member assemblies 132 corresponds to the number of guide
bodies 90 of the expansion assembly 36. With reference to FIG. 1C,
each of the push the member assemblies 132 includes a needle
catheter 134, a push member 136 disposed within the needle catheter
134, a needle 138 removably affixed to the push member 136, and a
suture 140 affixed to the needle 138. While one of the push member
assemblies 132 is described in greater detail below, it is to be
understood that each of the plurality of push member assemblies 132
can incorporate similar features.
[0055] With reference to FIG. 1A, in one embodiment, the needle
catheter 134 defines a proximal end 142 and extends a length to
define a distal end 144. The needle catheter 134 can be of a type
similar to those generally known in the art. The length of the
needle catheter 134 extends sufficiently such that the proximal end
142 of the needle catheter 134 can be manipulated from outside the
body of a patient (not shown) while the catheter distal end 142 is
affixed to the distal end 114 of the first one of the plurality of
projections 90. Manners of affixing the distal end 142 to the
distal end 114 include such techniques as sonic or laser welding,
for example. In one embodiment, the outer diameter of the needle
catheter 134 is such that a plurality of needle catheters included
in the plurality of push member assemblies 132 and similar to the
needle catheter 134, can be disposed within the inner lumen 34 of
the second unit body 32. The inner diameter of the needle catheter
134 is preferably such that the push member 136 can be disposed
within the needle catheter 134.
[0056] In one embodiment, the push member 136 defines a proximal
end 146 and extends a length to a distal end 148. As mentioned
above, the push member 136 is disposed within the needle catheter
134. As described in greater detail below, the length of the push
member 136 preferably extends sufficiently such that a proximal end
146 of the push member 136 extends from the catheter proximal end
142 and can be manipulated from outside of the patient (not shown),
while the distal end 148 of the push member 136 extends from the
catheter distal end 144. The push member 136 is made of a material
such as Nitinol.RTM. wire, or plastic, for example. In particular,
the push member 136 is preferably configured such that an operator
(not shown) can impart a push force on the push member proximal end
146 with a resultant push force being translated to the push member
distal end 148.
[0057] With reference again to FIG. 1C, in one embodiment, the
needle 138 includes a base 150 configured to be removably affixed
to the push member distal end 148. This relationship can be
accomplished via means generally known in the art, including
interference fits, semi-permanent glues, operatively breakable
welds, magnets, actuated clips, operatively breakable lashes, and
others. Further, the needle 138 is configured for affixment to the
suture 140. In one embodiment, the needle 138 also includes a barb
152. In particular, the barb 152 can be configured to aid in
capturing the needle 138 with the suture receiving portion 29 of
the first unit 22.
[0058] In one embodiment, the suture 140 extends continuously from
a first end 154 to a second end 156 (FIG. 2A). As described above,
the first end 154 is preferably adapted to be affixed to the needle
138. In one embodiment, the second end 156 is affixed to a needle
157 (shown in dotted lines in FIG. 2A) of another one of the
plurality of push member assemblies 132.
[0059] In one embodiment, the suture delivering portion 36 defines
a non-extended state, including the needle 138 residing within the
needle catheter 134 proximate the needle catheter distal end 144.
The push member 136 can then be moved distally from outside the
body of the patient (not shown) to transition to the suture
delivering portion 36 to an extended state such that the needle 138
extends from the needle catheter distal end 144 sufficiently to
drive the needle 138 through the septum as desired (not shown).
[0060] The repair device 20 is shown in FIGS. 1A and 1B with the
second unit 30 in the collapsed state. The plurality of guide
bodies 90 and the plurality of pockets 88 are preferably assembled
together to define the collapsed state as follows. Each of the
plurality of guide bodies 90 is maintained within a corresponding
one of the plurality of pockets 88 such that the plurality of guide
bodies 90 do not protrude, or extend outwardly from the
corresponding pockets 88. In other words, the plurality of guide
bodies 90 generally lie "in plane" with the corresponding pocket 88
and a surrounding portion of the second unit body 32.
[0061] As alluded to above, the pin 92 acts to help maintain the
corresponding guide body 90 within the respective pocket 88. In
particular, the pin central portion 122 is rotatably and slidably
maintained in the pin slot 116 while the pin ends 124,126 are
maintained in the female pin mounts 102,106. With this arrangement,
the pin 92 can be slid within the pin slot 116 and rotated about
the pin 92. Further, the female pin mounts 102,106 can also be
configured to allow the pin ends 124,126 to rotate within them. As
will be described in greater detail below, rotation of the guide
body 90 about the pin 92 can facilitate extension of the distal end
114 of the guide body 90 from the corresponding pocket 88 in a
manner somewhat similar to that described in association with the
first unit 22.
[0062] In one embodiment, the actuation wires 94 extend through a
corresponding channel 166 formed through the thickness of the
second unit body 32. In particular, each actuation wire 94
preferably extends proximally beyond the body proximal end 84.
However, each actuation wire 94 can alternatively take an external
path to the body 32 to extend beyond the body proximal end 84.
Further, each actuation wire 94 can also extend over an internal
path, e.g., within the inner lumen 34, to extend beyond the body
proximal end 84. In one embodiment, the actuation wire proximal end
128 extends a sufficient length such that an operator (not shown)
is capable of manipulating the actuation wire proximal end 128 from
outside the patient (not shown). As described below, pulling or
proximal force on the actuation wire 94 can act to maintain the
corresponding guide body 90 "in plane" as shown in FIGS. 1A and 1B,
while pushing or distal force on the actuation wire 94 acts to
extend the corresponding guide body 90 "out of plane."
[0063] As mentioned above, each of the plurality of push member
assemblies 132 can be affixed to the corresponding distal end 114
of a respective one of the plurality of guide bodies 90. More
specifically, the distal end 44 of the needle catheter 134 is
affixed to the distal end 114 such that the lumen of the needle
catheter 134 is arranged perpendicularly to the length of the
corresponding guide body 90. In this manner, the lumen of the
needle catheter 134 can be directed toward a septum (not shown)
when the second unit 30 is in the expanded state. Means of affixing
the needle catheter 134 to the corresponding guide body 90 can
include those generally known in the art, including, but not
limited to, welds, glues, magnets, lashes, clamps, and others.
[0064] With reference from FIGS. 1A and 1B to FIGS. 2A and 2B, a
manner of expanding the second unit 30 from the collapsed state
(FIGS. 1A and 1B) to the expanded state (FIGS. 2A and 2B) follows.
In particular, pushing, or distal movement of the actuation wires
94 preferably results in the plurality of guide bodies 90 sliding
distally on the corresponding pin slot 116 over the respective pin
92. In one embodiment, the distal end 110 of the each of the
plurality of guide bodies 90 is configured such that it is guided
by the distal end 100 of the corresponding pocket 88 outward from
the central longitudinal axis X as it is moved distally by the
corresponding actuation wire 94. In this manner, each of the
plurality of guide bodies 90 will preferably also rotate about the
corresponding pin 92 as it moves distally. In one embodiment, the
actuation wires 94 are connected to the proximal end 110 of the
corresponding guide body 90 at an offset toward the central
longitudinal axis X. In the embodiment, this configuration aids in
directing the proximal end 110 toward the longitudinal axis X,
resulting in direction of the distal end 114 outward, away from the
longitudinal axis X in a sliding "see-saw" manner.
[0065] As the guide body 90 slides distally and the distal end 114
rotates outwardly, the pin 92 eventually reaches the proximal end
118 of the pin slot 116. Once the proximal end 118 has been
reached, the guide body 90 extends at a perpendicular angle to the
central longitudinal axis X. In light of the description provided
herein, means of accomplishing this perpendicular extension via
distal actuation, or pushing, will be recognized by those having
ordinary skill in the art. For example, one such means includes
incorporation of a cam structure into the pin 92 configured to
interact with the female pin mounts 102,106 and/or the pin slot
116. A manner of retaining the guide bodies 90 in the perpendicular
position shown includes maintaining the actuation wire 94 in a
fixed position after the corresponding guide body 90 has been
extended.
[0066] Similarly to the first unit 22, it should also be recognized
that the second unit 30 can be collapsed, or transitioned from the
expanded state to the collapsed state shown in FIGS. 1A and 1B. In
particular, transitioning the second unit 30 from the expanded
state to the collapsed state can include proximal actuation, or
pulling, of the actuation wires 94 to effectuate a reverse series
of motions to those described in association with expansion of the
second member 30. In other words, expanding the second unit 30
includes pushing on the actuation wires 94, while collapsing the
second unit 30 includes pulling on the actuation wires 94. However,
those of ordinary skill in the art will recognize that alternative
means of either expanding, or collapsing the second unit 30, and in
particular, actuation of the plurality of guide bodies 90, can be
employed. For instance, in alternative embodiments, spring
mechanisms or balloons can be included in the second unit 30 in
order to facilitate expanding or the collapsing the second unit
30.
[0067] As mentioned above, the first and second units 22,30 are
configured for catheter insertion into the body of the patient (not
shown). Generally, the first unit 22 is slidably disposed about the
second unit 30. More specifically, the first unit body 24 is
slidably disposed about the second unit body 32, such that the
second unit 30 can be extended from the first unit body 24 but
cannot be rotated therein. In one embodiment, an operator (not
shown) manipulates the first unit body proximal end 40 and the
second unit body proximal end 84 from outside the body of the
patient (not shown) to effectuate relative extension. With this
configuration, the suture delivering portion 36 of the second unit
30 can be extended while remaining aligned with the suture
receiving portion 29 of the first unit 22. For example, and as
shown in FIGS. 1A, 1B, 2A and 2B, the non-rotatable configuration
allows both units 22,30 to be transitioned to the expanded state
with the second unit plurality of guide bodies 90 aligned with the
first unit plurality of projections 44.
[0068] As such, the second unit 30 is extended from the first unit
inner lumen 26 prior to transitioning to the expanded state in the
manner described above. As will be described in greater detail
below, this slidable and nested configuration also allows the
repair device 20 to reside on two sides of a septal defect (not
shown) in order to opposingly anchor the structures surrounding the
septal defect between the two units 22,30.
[0069] Additionally, the first unit 22 can alternatively be
configured to be disposed within the second unit 30. Indeed, it is
to be understood that in embodiments of the present invention, the
features described in association with the first and second units
are interchangeable. For example, the first unit 22 can include the
suture delivering portion 36 while the second unit 30 includes the
suture receiving portion 29.
[0070] With that in mind, and with reference to FIGS. 3-12B, a
system and method of repairing a congenitally defective heart 200
can be described. For those not familiar with the nomenclature
commonly associated with cardiac structures, the designation "left"
or "right" corresponds to the "left" and "right" of the patient
(not shown) and should be interpreted accordingly. The heart 200 is
shown from a front of the patient (not shown) and generally
includes a right atrium 202, a left atrium 204, a right ventricle
206, and a left ventricle 208. An inferior vena cava 210 and a
superior vena cava 212 also lead into the right atrium 202. A
septum divides the heart 200 into a right half and a left half.
More specifically, the septum includes an atrial septum 214 and a
ventricular septum 216. The atrial septum 214 separates the right
and left atria 202,204 while the ventricular septum 216 separates
the right and left ventricles 206,208.
[0071] The atrial septum 214 is formed by septal tissue and
includes a septum primum 218 and a septum secundum 220. Prior to
childbirth the septum primum 218 and the septum secundum 220 define
a passageway for blood between the right and left atria 202,204
Following childbirth, the passageway will close in a healthy heart
(not shown). As shown, the heart 200 includes a septal defect 222
in the form of such a passageway, a patent foramen ovale. In one
embodiment, the patent foramen ovale occurs due to improper
formation of the septum primum 218. In other embodiments, the
patent foramen ovale occurs due to improper formation of the septum
secundum 220, or both the septum primum 218 and the septum secundum
220.
[0072] Furthermore, while embodiment methods of repairing a
congenital heart defect will be described in association with the
septal defect 222 including the patent foramen ovale, it is to be
understood that the principles and embodiments described herein can
be applied to other types of congenital heart defects, including,
for example, ventricular septal defects.
[0073] In one embodiment, a guide wire 225 is introduced into the
body of the patient (not shown) via a sheath in the femoral artery
(not shown). The guide wire 225 is introduced into the heart 200 in
a manner known in the art. In one embodiment, the guide wire 225 is
a J-Tip wire. A guide catheter 226 is then threaded over the guide
wire 225 and into the heart 200. Generally, the guide catheter 226
will be introduced into one or more bodily lumens and delivered to
the heart 200. In one embodiment, a distal portion 228 of the guide
catheter 226 is guided from one bodily lumen the femoral artery to
the heart 200 via the inferior vena cava 210 and into a right
atrium 202. In an alternative embodiment, the heart 200 can be
entered from a left atrial or left ventricular side. However, such
an approach is known to increase the risk of forming blood clots.
The guide catheter 226 so disposed includes a proximal portion (not
shown) of the guide catheter 226 remaining exposed outside of the
body of the patient. Further, the guide catheter 226 is preferably
configured such that the distal portion 228 is capable of being
selectively angled by an operator (not shown) from outside of a
body of a patient (not shown) toward the septal defect 222.
[0074] With reference to FIG. 4, one embodiment method of guiding
the repair device 20 into the left atrium 204 via the guide
catheter 226 includes piercing, or puncturing, the septum 214 with
a transseptal needle 234. In one embodiment, the repair device 20
(hidden in FIG. 4) is guided into the left atrium 204 over the
guide wire 225 (FIG. 3) through the guide catheter 226. More
specifically, once the guide catheter 226 and guide wire 225 have
been disposed within the right atrium 202, the repair device 20 is
preferably threaded over the guide wire 225, through the guide
catheter 230, and into the right atrium 202. As discussed above,
the second unit 30 is preferably slidably disposed within the first
unit 22. In one embodiment, the guidewire 225 is then removed and
replaced with the transseptal needle 234. As described above, the
guide catheter 226 is angled toward the septal defect 222 in order
to direct the repair device 20 and the transseptal needle 245 to
the septal defect 222. In another embodiment, the repair device 20
is configured such that the repair device 20 can be selectively
angled toward the septal defect 222 to guide the transseptal needle
245 proximate the septal defect 222.
[0075] In one embodiment including an inter cardiac echo catheter,
the repair device 20 is guided under inter cardiac echo to a
desired position proximate the septal defect 222. In one exemplary
embodiment, the desired position is proximate the septum primum
218. Once properly positioned, the transseptal needle 234 is used
to puncture the atrial septum 214. In one embodiment, the septal
tissue defining the septum primum 218 and the septum secundum 220
is punctured. Once the septal tissue defining the atrial septum 214
has been punctured, the transseptal needle 234 extends between the
right atrium 202 and the left atrium 204. The repair unit 20 is
extended from the guide catheter 226 and over the transseptal
needle 234 as shown in FIG. 5. The transseptal needle 234 is
removed from the repair device 20 and out of the body of the
patient (not shown).
[0076] With reference from FIG. 5 to FIG. 6, the second unit 30 is
preferably sufficiently advanced into the left atrium 204 such that
the second unit 30 can transition to the expanded state. Once the
second unit 30 has been sufficiently advanced, the transseptal
needle 234 (not shown) can be removed from the repair device 20 and
taken completely out of the patient (not shown).
[0077] Other methods of guiding the repair device 20 from the right
atrium 202 to the left atrium 204 can also be employed. Another
embodiment method of delivering the repair device 20 from the right
atrium 202 to the left atrium 204 includes removing the guide wire
225 from the guide catheter 226 and inserting a transseptal needle
234 into the guide catheter 226 prior to inserting the repair
device 20 into the guide catheter 226. In particular, the
transseptal needle 234 is guided to the atrial septum 214 proximate
the septal defect 222. The transseptal needle 234 is then used to
puncture the atrial septum 214, and in one embodiment, the septum
primum 218 and septum secundum 220. The guide catheter 226 can then
be guided over the transseptal needle 234 into the left atrium 204.
The transseptal needle 234 is removed from the guide catheter 226
and replaced with the repair device 20. The repair device 20 can
then be delivered into the left atrium 204 via the guide catheter
226. In another embodiment method of guiding the repair device 20
into the right atrium 202, the atrial septum 214 is punctured with
a suitably configured tip of the guide catheter 226, or
alternatively, the repair device 20, to deliver the repair device
20 to the left atrium 204. In yet another embodiment, the guide
catheter 226 is guided through the septal defect 222 itself to the
left atrium 204 without puncturing the atrial septum 214. In
another embodiment, the repair device 20 is guided through the
septal defect 222 between the atria 202,204 (i.e., the septum 214
is not initially punctured).
[0078] With reference to FIG. 7, in one embodiment method, when the
second unit 30 is appropriate disposed in the left atrium 204, it
is then expanded to the expanded state. The first unit 22 is also
sufficiently extended from the guide catheter 226 and transitioned
to the expanded state. The first unit 22 and the second unit 30 are
then opposingly contacted with a first side 236 and a second side
238 the septum 214. In particular, the plurality of guide bodies 90
is pulled against the second side 238 of the septum 214 while the
plurality of projections 44 is pushed against the first side 236 of
the septum 214. In one embodiment, the second unit 30, and in
particular the body proximal end 84 (not shown) is pulled back, or
moved proximally, in order to make contact with the atrial septum
214 while the first unit body proximal end 40 (not shown) is pushed
from outside the patient (not shown). In one embodiment, and as
shown in FIG. 7, the plurality of guide bodies 90 is abutted
against the septum secundum 220 and the plurality of projections 44
are contacted with the septum primum 218. Thus, the two units 22,30
are opposingly contacted with the septum 214. With this opposing
contact, the first unit 22 and the second unit 30 press portions of
the atrial septum 214 proximate the septal defect 222 to press or
perhaps anchor or lock the atrial septum 214 in place between the
two units 22,30 of the repair device 20.
[0079] As mentioned above, in one embodiment, the second unit 30 is
prevented from rotating within the first unit 20. Along these
lines, the generally rectangular cross-sections of both the first
and second units 22,30 can act to prevent relative rotation of the
two units 22, 30. With this configuration, the plurality of
projections 44 of the first unit 22 in the plurality of guide
bodies 90 of the second unit 30 are maintained in an aligned
position. Particularly, each one of the plurality of projections 44
residing on one side of the septum 214 is aligned to a
corresponding one of the plurality of guide bodies 90 residing on
the opposite side of the septum 214. In one embodiment, the
alignment of the plurality of guide bodies 90 with the plurality of
projections 44 results in each one of the plurality of push wire
assemblies 132, and in particular, the needle catheter distal end
144 being aligned with the suture receiving portion 29 defined, or
otherwise included, by each one of the plurality of projections
44.
[0080] With reference to FIG. 8, the suture delivering portion 36
is then used to drive the suture 140 through the atrial septum 214
at a first location proximate the septal defect 222. In one
embodiment, the push member 136 is manipulated from outside of the
patient (not shown) in a distal direction to extend from the needle
catheter 134. In other words, each push member 136 is pushed
distally such that the needle 138 affixed to the corresponding push
member 136 extends from the corresponding needle catheter 134 and
is driven through the atrial septum 214, and in particular the
tissue defining the atrial septum 214, with the suture first end
154 in tow. In one embodiment, both the septums primum and secundum
218,220, are fully pierced with the first end 154 of the suture 140
in tow. As shown, the needles 138 are pushed through the atrial
septum 214 and into the suture receiving portion 29 of the first
unit 22 to be captured or retained therein. As shown in FIG. 8, the
suture receiving portion 29 includes one of the plurality of
projections 44 being formed of wire mesh such that when the barb
152 of the needle 138 is passed into the mesh, the needle 138 is
anchored therein.
[0081] With reference to FIG. 9, the push members 136 (not shown)
are then pulled, or moved, proximally from outside the patient (not
shown) in order to retract the push members 136 back into the
corresponding needle catheter 134. As mentioned above, the needle
138 is preferably removably affixed to the corresponding push
member 136, such that pulling, or proximal movement of the push
member 136 results in separation of the push member 136 from the
needle 138. With the needle 138 captured by the suture receiving
portion 29 of the first unit 22, along with the suture first end
154, the push member 136 is then removed from the atrial septum 214
and back into the needle catheter 134. As shown, the second end 156
of the suture 140 affixed to the second needle 157, is driven
through the tissue at a second location and anchored, or captured
within the suture receiving portion 29 of the first unit 22 in a
similar manner. As will be described below, the two ends 154,156
can then be tied together once the first unit 22 is removed from
the body of the patient (not shown) with the ends 154,156 in tow.
In one embodiment, needles affixed to two ends of a second suture
158 are also driven through the tissue of the atrial septum 214 at
a third and a fourth location proximate the septal defect 222 and
into other ones of the plurality of projections 44 in a similar
manner. It should be understood that embodiments of the method
generally include a plurality of sutures being driven through the
atrial septum 214 such that a first end and a second end of each of
the plurality of sutures is captured by the suture receiving
portion 29.
[0082] In one embodiment, once the suture 140 and second suture 158
have been captured by the first unit 22, the second unit 30 is
transitioned back to the collapsed state. Following transitioning,
the second unit 30 is retracted from the left atrium 204 and back
within the first unit 22. In one embodiment, a hole remains where
the septum 214 was punctured upon retrieval of the second unit 30
from the left atrium 204. In another embodiment, the natural
elasticity of the septum 214 causes the hole to contract such that
it is substantially closed.
[0083] In FIG. 10, the second unit 30 (hidden) has been retracted
into the first unit 22. The first unit 22 also transitions back to
the collapsed state once the sutures 140, 158 have been captured.
In one embodiment, the first end 154 and the second end 156 of the
suture 140, and the first and second ends of the second suture 158
are drawn toward the central axis X (FIG. 1A) of the repair device
20 and into the plurality of nests 42.
[0084] With reference to FIG. 11, the first unit 22 is retracted
from the right atrium 202 and into the guide catheter 226 with the
first and second ends 154,156 of the suture 140 and the first and
second ends of the second suture 158 in tow. In this manner, an
operator (not shown) can access the ends of the sutures 156,158
from outside of the body of the patient (not shown). As shown in
FIG. 11, the two ends 156,158 can then be tied into a first knot
160, such as a simple suture. In one embodiment, a knot pusher (not
shown) is used to push the first knot 160 formed in the suture 140
outside of the body of the patient back through the guide catheter
226 and to the atrial septum 214. The excess material of the suture
140 surrounding the first knot 160 can then be clipped. In one
embodiment, the knot pusher includes a clipping mechanism (not
shown). A similar method can be used to tie a knot 162 (FIG. 12A)
in the second suture 158. As shown, the hole punctured in the
septum 214 is at least partially closed with the knot 162 adjacent
the septum 214.
[0085] With reference to FIGS. 12A and 12B, a preferred
configuration of the sutures 140, 158 and their corresponding knots
160,162 can be described. In particular, FIG. 12A shows one
preferred configuration from a viewpoint of the right atrium 202.
Conversely, FIG. 12B shows a preferred configuration from a
viewpoint of the left atrium 204. As shown, the two sutures 140,158
act to maintain the atrial septum 214 in a closed position in order
to repair the septal defect 222 (not shown). Furthermore, in one
embodiment, the hole punctured in the septum is also drawn closed
by the two sutures 140,158. In another embodiment, the sutures
140,158 can be used to repair a hole through the ventricular septum
216 (not shown). In another alternative embodiment, a patch (not
shown) of a type known in the art can be sutured to one side of the
septum 214, or two patches can be sutured to opposing sides of the
septum 214, respectively. Regardless, the patch or patches can be
secured by one or both of the sutures 140 or 158 in conjunction
with the above method, or can be affixed separately.
[0086] As alluded to above, alternative embodiments also include
additional sutures and/or patches used to repair septal defects.
For example, a patch (not shown) could be delivered via the repair
device 20 to the area approximate the septal defect 222 and sutured
thereto utilizing an embodiment method of the present invention.
Additionally, another embodiment of the present invention can
include suturing an occlusion device proximate a septal defect.
Furthermore, alternative suture configurations, including
non-crossed configurations as otherwise shown in FIGS. 12A and 12B,
are also incorporated in alternative embodiments. It is also to be
understood that in one exemplary embodiment wherein the first unit
22 includes a suture delivering portion and the second unit 30
includes a suture receiving portion, the views of FIGS. 12A and 12B
can be reversed such that FIG. 12A would show a view from the left
atrium 204.
[0087] Although specific embodiments have been illustrated and
described herein, it will be appreciated by those of ordinary skill
in the art that a variety of alternate and/or equivalent
implementations may be substituted for the specific embodiments
shown and described without departing from the scope of the present
invention. For example, FIGS. 13A and 13B illustrate an alternative
embodiment first unit 321 of a repair device 320 in accordance with
the present invention. Generally, the first unit 321 comprises a
body 322 and an expansion assembly 324. In particular, the
expansion assembly 324 includes a mesh hood 326 and an actuation
catheter 327.
[0088] The body 322 is preferably formed of materials similar to
those known in the art. In one embodiment, the body 322 is a
catheter and defines a generally circular transverse cross-section
forming an inner lumen 328. The body 322 extends from a proximal
end (not shown) to a distal end 332. Further, the body 322 defines
a length sufficient to allow manipulation of the proximal end while
the distal end 332 is proximate a septal defect (not shown). In one
embodiment, the body 322 is configured for insertion into the
actuation catheter 327.
[0089] The actuation catheter 327 of the expansion assembly 324 can
be a catheter of a type generally known in the art. Generally the
actuation catheter 327 defines an inner lumen 334, a proximal end
(not shown) and a distal end 338. As described above, the inner
lumen 334 is preferably configured to accept the body 322.
Additionally, the actuation catheter 327 preferably extends a
length sufficient to allow manipulation of the proximal end from
outside the body of the patient (not shown) while the distal end
338 is disposed proximate a septal defect (not shown).
[0090] As shown in FIG. 13A, the hood 326 is affixed to the body
322. The hood 326 is preferably configured to expand outwardly from
a central longitudinal axis Y of the first unit 321 when
unconstrained by the actuation catheter 327. In particular, the
hood 326 can be formed of Nitinol.RTM. mesh, or another metal
capable of incorporating a spring action. Alternatively, the hood
326 can be formed of expandable plastic structure. Preferably a
spring action allows the hood 326 to spring between a configuration
substantially perpendicular to the central longitudinal axis Y
(FIG. 13B) to a configuration substantially parallel to the central
longitudinal axis Y (FIG. 13A). Additionally, the hood 326 is also
configured to define a suture receiving portion 329 of the repair
device 320. In particular, a thickness of the hood 326 is
configured to retain a first end of a suture (not shown).
[0091] As such, assembly of the body 322 and actuation catheter 327
can be described as follows. The hood 326 is affixed to the distal
end 332 of the body 322. Preferably, both the body 322 and the hood
327 affixed thereto are slidably disposed within the inner lumen
334 of the actuation catheter 327.
[0092] A method of transitioning the first unit 321 to an expanded
state includes sliding the body 322 and the actuation catheter 327
relative to one another such that the hood 326 is exposed from the
distal end 338 of the actuation catheter 324. The spring action of
the hood 327 causes the hood 327 to transition to a configuration
substantially perpendicular to the central longitudinal axis Y
(FIG. 13B). Another alternative embodiment a repair device further
comprises a second unit substantially similar to the first unit
321, but configured to be slidably disposed within the first unit
321. In another embodiment, the second unit is substantially
similar to the second unit 30 of the repair device 20.
[0093] Another alternative embodiment repair device 420 in
accordance with the present invention is shown in FIG. 14.
Generally, the repair device 420 includes a body 422, an expansion
assembly 424, a suture receiving portion 425, and a suture
delivering portion 426.
[0094] The body 422 can be formed of materials similar to those be
used in association with catheters known in the art. The body 422
is configured to be coaxially received within an inner lumen of a
guide catheter (not shown). The body 422 also defines a central
lumen 428 of the repair device 420.
[0095] The expansion assembly 424 can be described as similar to
those previously described in association with other embodiments.
Generally, the expansion assembly can include a plurality of
projections 430 that can be actuated with actuation wires 432. In
the embodiment, the repair device 420 includes two projections 430,
a first one 434 formed of a solid material and configured such that
a distal end 436 of the first one 434 can be affixed to the suture
delivery portion 426. A second one 438 of the plurality of
projections 430 can be formed of a wire mesh material to define the
suture receiving portion 425 of the repair device.
[0096] The suture delivering portion 426 of the repair device 420
can include a needle catheter 440, a push member 442, a suture
needle 444, and a suture 446. The needle catheter 440 is configured
to slidably accept the push member 442 within an inner lumen (not
shown) of the needle catheter 440.
[0097] The push member 442 is configured to transition to adopt a
curvilinear shape upon extension from the needle catheter 440. In
particular, the push member 442 can be made of a shape memory
metal, such as Nitinol.RTM., with a naturally occurring curve
resulting in the push member when it is unconstrained by the needle
catheter 440.
[0098] The suture needle 444 and the suture 446 can be largely
similar to those previously described. As such, the suture needle
444 can be removably affixed to the push member 442 at a distal end
448 of the push member 442. In another embodiment, the suture
needle 444 is configured to transition to adopt a curvilinear shape
upon extension from the needle catheter 440. In the embodiment
shown, the suture 446, and in particular, a first end 450 of the
suture 446 is affixed to the suture needle 444. In another
embodiment, the first end 450 is removably affixed to the suture
needle 444.
[0099] In one embodiment, the needle catheter 440 is affixed to the
first one 434 of the plurality of projections 430, such that when
the plurality of projections 430 are transitioned to an expanded
state and abutted against a septum 452 the suture needle is
positioned at a first location L1 proximate a septal defect
410.
[0100] In a related embodiment, the repair device 420 further
includes a second unit (not shown) similar to that of the first
unit 321 of the repair device 320. The repair device 420 can also
include a second unit (not shown) similar to the first unit 22 or
the second unit 30 of the repair device 22. With the addition of
the second unit to the repair device 420, the septum (not shown)
can be anchored between the expansion assembly 424 and the second
unit to facilitate suturing in a manner similar to that described
above in association with other embodiments.
[0101] As such, a method of repairing a septal defect includes
expanding the plurality of projections 430 to an expanded state and
abutting the plurality of projections against a first side 454 of
the septum 452, such that the suture needle 444 is positioned at a
first location proximate the septal defect 410. The suture needle
444, with the first end 450 of the suture 446 affixed thereto, is
extended from the needle catheter 440 by actuating the push member
442 from a location outside of the patient (not shown). As the
suture needle 444 is extended from the needle catheter 440, the
suture needle 444 is driven through the septal tissue at the first
location from the first side 454 to a second side 456 of the septum
452. As shown in FIG. 14, the push member 442 extends in a
curvilinear manner as it is extended further from the needle
catheter 440 until the suture needle 444 is positioned at a second
location L2 proximate the septal defect and driven through the
tissue of the septum 452 from the second side 456 to the first side
454 and into the suture receiving portion 425.
[0102] The suture needle 444 is received within the receiving
portion 425, and upon retraction of the push member 442 back into
the needle catheter 440, remains captured therein with the first
end 450 of the suture 446 affixed thereto and also captured
accordingly. In an alternative embodiment including the first end
450 being removably affixed to the suture needle 444, the suture
needle remains affixed to the push member 442 while the first end
450 of the suture 446 is captured within the capture portion 425
upon retraction of the push member 442. The expansion assembly 424
can then be transitioned back to the collapsed state and retracted
from the patient with the first end 450 of the suture 446 in tow.
In this manner, an operator can thereby tie the first end 450 of
the suture 446 and a second end (not shown) of the suture 446 in
order to repair the septal defect 410, or alternatively suture a
patch thereto, for example.
[0103] As mentioned above, alternative embodiment repair devices
can also include a balloon as an expansion means for either a first
unit or a second unit of the alternative embodiment repair device.
For example, in one embodiment, the repair device includes a
balloon mounted on a catheter. In particular, the balloon can
define a generally hourglass shape in an expanded state, such that
the balloon can anchor septal tissue proximate a septal defect
between two opposing hourglass portions of the balloon. With the
alternative embodiment, a suture delivering portion similar to that
described above is mounted on one hourglass portion of the balloon
while a suture receiving portion is mounted on the opposite
hourglass portion of the balloon. In one embodiment, the suture
receiving portion includes a plurality of funnels defining a
generally conical shape and having a porous material at a base of
each of the funnels. The plurality of funnels is radially disposed
about the one hourglass portion of the balloon with a plurality of
push wire assemblies disposed about the opposite hourglass portion
of the balloon. The plurality of funnels and the plurality of push
wire assemblies are aligned with one another such that a plurality
of needles affixed to a plurality of suture ends can be extended
from each of the plurality of push wire assemblies into each of the
plurality of funnels following expansion of the balloon.
[0104] As such, one embodiment method of repairing a septal defect
utilizing the alternative embodiment repair device can include the
following: guiding the repair device to an area approximate a
septal defect; guiding the repair device through the septum;
expanding the balloon of the repair device to the expanded state to
press the septum; actuating the suture delivering portion to drive
a plurality of suture ends through the tissue defining the septum
and into the suture receiving portion of the repair device;
transitioning the balloon back to a collapsed state; retracting the
repair device form the body with a plurality of suture ends in tow;
and tying the plurality of suture ends.
[0105] Additionally, alternative sewing assemblies, such as, for
example, a repeating mechanical sewing machine are also included
within the scope of the present invention. For example, in another
alternative embodiment, a repeating mechanical sewing machine
includes a first unit acting analogously to a bottom mechanism of a
sewing machine with a second unit including a needle pusher acting
analogously to a needle driving portion of a sewing machine. In one
embodiment, the two units are configured to be rotated in concert
while aligned on opposing sides of a septal defect. As the two
units are rotated, the needle pusher repeatedly drives a needle
that is carrying a portion of a suture through the septum and to
the first unit such that the suture is continuously and repeatedly
driven through the septum at various locations proximate the septal
defect. In this manner, the suture can then be "tightened up" and
the septal defect sewn shut.
[0106] In light of the above, an improved manner of repairing
congenital defects via less invasive means, including repairing
those defects not amenable to the use of occlusion devices, is
presented herein. In particular, those of ordinary skill in the art
will understand the text above and accompanying figures to present
a method and apparatus capable of allowing a surgeon to suture
septal tissue proximate a septal defect with less invasive methods
than those related to accessing the heart through the chest of a
patient. This application is intended to cover any adaptations or
variations of the specific embodiments discussed herein. As such,
it is intended that this invention be limited only by the claims
and the equivalents thereof.
* * * * *